BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 8903690 · Received August 16, 2019

    Report

    Report Number
    2017865-2019-12232
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    August 1, 2019
    Report Date
    September 10, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    UDI-DI
    05414734502894
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED NOTES THAT REPRODUCIBLE NOISE WAS OBSERVED DURING AN IN-CLINIC FOLLOW UP. IT WAS ALSO OBSERVED THAT PACING IMPEDANCE DECREASED. FURTHER PROGRAMMING ADJUSTMENT WERE PERFORMED. A CHEST X-RAY FOUND NO LEAD INTEGRITY ANOMALIES, HOWEVER UNRELATED PATHOPHYSIOLOGIC CHANGES WERE NOTED. THE PATIENT WAS SINCE REPORTED AS DECEASED. THE PHYSICIAN HAD DENIED THE PRODUCT CONTRIBUTED TO THE PATIENT'S DEATH.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP IN-CLINIC EXHIBITING LEAD IMPEDANCE VALUES LESS THAN THE LOWER LIMIT. ISOMETRIC TESTING WAS PERFORMED AND NOISE WAS OBSERVED ON THE VENTRICULAR SENSE ELECTROGRAM. PROGRAMMING INTERVENTIONS WERE MADE. THE PATIENT WAS STABLE, AND WILL CONTINUE WITH MONITORING AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694439 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/58 A000024122 05414734502894

    Patients

    Seq Age Sex Outcome Treatment
    1